To ensure the highest quality services, our laboratories implemented and maintains internationally recognized quality standards. As European Biomedical Institute we are:
US FDA 21CFR58 compliant
Quality system, that defines a set of rules and criteria for studies that are planned, performed and monitored, and their results are recorded, reported and archived. It is possible to trace the course of the study or its complete reconstruction. European Biomedical Institute is GLP certified.
The quality management standard, implemented to standardize the technical requirements and requirements of management system, intended for research laboratories in terms of testing and calibration. The objective of ISO 17025 is to promote the confidence in the operation of laboratories, to enable them to demonstrate they operate competently, and are able to generate valid results. European Biomedical Institute is ISO 17025 accredited.
US FDA 21CFR58
Code of Federal Regulations of good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the FDA.
According to the ISO 10993-1:2018, B.4.5.3 any testing to support a biological evaluation have to be conducted in appropriate quality systems. The quality systems controls applicable to biocompatibility testing are known as Good Laboratory Practices (GLP). GLP studies are carried out to defined quality standards in laboratories that are accredited in line with an internationally implemented governmental scheme. Those studies have to be conducted under a laboratory quality system compliant to ISO/IEC 17025 or an equivalent standard (GLP).
Furthermore, European Biomedical Institute is inspected and subject to constant supervision of the following Bodies:
Ministry of Science and Higher Education
If you have any further questions in terms of quality, please contact with us at firstname.lastname@example.org